Assay Mobile phase : dissoleve 2,2 g of docusate sodium in ml of glacial acetic acid and 500 ml of methanol in a 1000 ml volumetric

flask/ dilute with water to volume, and mix. Pass this solution through a membrane filter having a 1 micrometer or finer porosity Standard preparation: using vidarabine, prepare as directed for standard preparation. Cromatographic system : the choramotgraph is equipped with a 254nm detector and a 4-mm x 30 cm coloumn that contains packing L 1. Chromatograph three replicate injections of the standard preparation, and record the peak responses as directed for procedure : the relative standard deviation is not more than 3,0 %. Procedure : introduce equal volumes (approximately 10 microliter) of the assay preparation and the standard preparation into the instrument, operated at room temperature, by means of a suitable microsyringe or sampling valve. Adjust the operating conditions so that satisfactory chromatography and peak response are obtained. Use a detector sensitivity setting that gives a peak height for vidarabine that is at least 50% of scale. Measure peak responses at the same retention times obtained with the assay preparation and the standard preparation. Calculate the potency, in microgram of C10H13N5O4 per mg, of the vidarabine taken by the formula

Vidarabine opthalmic ointment Contains not less than 90% and not more 120% of the labeled amount of anhydrous vidarabine. Packaging: preserve in collapsible opthalmic ointment tubes. Sterility : it meets the requirements when tested as directed membrane filtration under test for sterility of the product to be examined. Minimum fill : meets the requirements Metal practice : it meets the requirements of the test for metal particles in opthalmic ointments Assay Mobile phase, standard preparation and chromatographi system proceed as directed in the assay of vidarabine Assay preparation : transfer an accurately wieghed portion of opthalmic ointment equivalent to about 12 mg of vidarabine, to a 100 ml volumetric flask, add 80 mL of water, and heat on steam bath for 15 minutes. Shake, and add 10 ml of n-heptane to the hot suspensuin. Swirl, and cool to room temperature. Remove the n-heptane layer, and discard it. Dilute the aqueous phase with water to volume and mix.

Procedure : proceed as directed in the assay under vidarabine. Calculate the potency.